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    • FDA Proposes Monograph for OTC Sunscreens Addressing Protection Against UVA and UVB LightAugust 29th, 2007

      On August 27, 2007, FDA published its long-awaited proposed rule to amend the final monograph for Over-the-Counter (“OTC”) sunscreen drug products.  The rule, if finalized, would set standards for formulating, testing, and labeling OTC sunscreen drug products with Ultraviolet A (“UVA”) light and Ultraviolet B …

    • Court Finds D.C. Law Prohibiting Patented Drugs from Being Sold for an Excessive Price Preempted by Federal Patent LawAugust 27th, 2007

      On August 1, 2007, the U.S. Court of Appeals for the Federal Circuit affirmed (errata) the U.S. District Court for the District of Columbia’s December 2005 ruling declaring that the District of Columbia’s Prescription Drug Excessive Pricing Act of 2005 (the “Act”) is preempted by …

    • HPM Announces New Of CounselAugust 26th, 2007

      Hyman, Phelps & McNamara, P.C. is pleased to announce that J.P. Ellison has joined the firm as Of Counsel.  Mr. Ellison joins HPM from the U.S. Department of Justice Office of Consumer Litigation (“OCL”).  By regulation, OCL has responsibility for representing the FDA, Federal Trade …

    • Managing Residual Risk – Words from the WiseAugust 22nd, 2007

      Hyman, Phelps & McNamara, P.C.’s Brian J. Donato cautioned companies about the dangers of “residual risk” while speaking at a recent conference on risk management sponsored by AdvaMed.  Medical Device & Diagnostic Industry reported on the speech in an August 2007 article.  Residual risk, which …

    • How Many Calories Are in the Big Apple? Court to Decide Whether New York City’s Regulation of Calorie Information on Restaurant Menus is Preempted by the NLEAAugust 21st, 2007

      The U.S. District Court for the Southern District of New York is expected to decide soon whether a New York City regulation requiring restaurants to post calorie content values on menus and menu boards is preempted by the Nutrition Labeling and Education Act of 1990 …

    • FDA Announces New Orphan Drugs DirectorAugust 20th, 2007

      Earlier today, FDA announced that Tim Coté, M.D., M.P.H., a Captain in the U.S. Public Health Service, has accepted the position of Director of the Agency’s Office of Orphan Products Development (“OOPD”).  Dr. Coté is only the fourth OOPD Director since the office was created …

    • Significant Marketed Unapproved Drugs FDA Enforcement Action In the Works at FDAAugust 20th, 2007

      Since FDA announced its current enforcement policy for marketed unapproved drug products in a June 2006 Compliance Policy Guide (“CPG”), the Agency has taken various company- and product-specific enforcement actions.  We have previously reported on some of these enforcement actions (here, here, and here).   FDA …

    • The Congress and Its Camel – the Expansion of User FeesAugust 15th, 2007

      Horace Scudder’s 1915 “The Book of Fables and Folk Stories” includes a story, titled “The Arab and His Camel,” that ends with the moral “It is a wise rule to resist the beginnings of evil.”  This is, of course, a parable of the Middle Eastern …

    • It’s All About “Substantial Evidence” for DDMACAugust 14th, 2007

      In two previous posts (here and here), we reported on a trend in Warning Letters issued by FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) that focuses on ensuring that promotional pieces contain substantial evidence to support advertising claims and proper presentations of safety …

    • CMS Final Rule on the Medicaid Drug Rebate ProgramAugust 9th, 2007

      We previously reported on some of the highlights of the most notable provisions of the final rule issued by the Centers for Medicare & Medicaid Services (“CMS”) on the Medicaid Drug Rebate Program.  Today, Hyman, Phelps & McNamara, P.C. issued a detailed memorandum summarizing the …

    • Is FDA Poised to Withdraw the First Subpart H Approval?August 9th, 2007

      In December 1992, FDA promulgated final regulations under which the Agency will accelerate the approval of certain new drugs and biologics for serious or life-threatening illnesses, and when such products provide a meaningful therapeutic benefit to patients over existing treatments. These regulations, which are commonly …

    • D.C. Circuit Court Rules in Abigail Alliance Case; Affirms District Court Ruling That There is No Fundamental Right of Access to Experimental Drugs for the Terminally IllAugust 7th, 2007

      On August 7, 2007, the U.S. Court of Appeals for the District of Columbia Circuit held in Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach in an 8-2 opinion “that there is no fundamental right ‘deeply rooted in this Nation’s history and …

    • House Passes FDA Appropriations Bill With Drug Importation ProvisionAugust 6th, 2007

      Last week, the U.S. House of Representatives passed H.R. 3161, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2008.  The bill, which, among other things, funds FDA’s discretionary spending for the upcoming fiscal year, “fully funds the …

    • The “Dog Ate My Homework Act” ResurfacesAugust 2nd, 2007

      Legislation that would permit the U.S. Patent and Trademark Office (“PTO”) to exercise discretion to accept untimely filed Patent Term Extension (“PTE”) applications has reportedly been added to the “Patent Reform Act of 2007” (S. 1145) by Senator Edward Kennedy (D-MA).  Representative William Delahunt (D-MA), …

    • Big Steps Ahead for the Nanotech IndustryAugust 1st, 2007

      Last week, FDA announced the publication of a report by the Agency’s Nanotechnology Task Force (“NTF”) that recommends that FDA develop guidance and take other steps to address regulatory and scientific issues related to nanotechnology.  Nanotechnology is an emerging field of applied science and technology …